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TerminatedNCT00523120Updated Apr 20, 2016

Topical Voltaren in Otitis Externa

A Phase 2 interventional study of diclofenac sodium and dexotc in Otitis Externa, sponsored by Sieff Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-20.

Sponsored by Sieff Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.

Read the detailed description

anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids

02

Conditions studied

  • Otitis Externa
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults having otitis externa as single diagnosis mild to moderate

Exclusion criteria

Exclusion Criteria:

  • Diabetes
  • Children
  • Pregnant women
  • Immune compromise
  • Starting other treatment
  • Moderate to severe otitis externa
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    1

    voltaren ophta

    Drug: diclofenac sodium

  • Active comparator
    2

    dexotic

    Drug: dexotc

Interventions

  • Drugdiclofenac sodium

    topical solution used in ear 5 drops 8 3/day

    Also known as: voltaren ophta

  • Drugdexotc

    aural drops

    Also known as: dexotic

05

What researchers measure

Primary outcomes

  1. reducing oral analagestic use

    Time frame: 1 week

Secondary outcomes

  1. adding an alternative treatment for otitis externa

    Time frame: 1 week

06

Study locations

1 site
  • Sieff Medical Center
    Safed, 13100, Israel
07

References and documents

08

Registry details

Key details

Study ID
NCT00523120
Lead sponsor
Sieff Medical Center
Responsible party
victor kizhner (Victor Kizhner MD, Sieff Medical Center) — Principal investigator
First posted
Aug 30, 2007
Start date
Sep 2008
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Apr 20, 2016

Study contacts

victor kizhner, m.d.
principal investigator · Sieff Medical Center, Safed, ISRAEL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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